The European Medicines Agency (EMA) has started a review of Esmya after four reports of serious liver injury, three of which ended in liver transplantation, in patients treated with the medicine.

“Based on the clinical data at our disposal, we consider that there is no demonstrable link between liver damage and treatment with Esmya,” spokeswoman Zsuzsa Beke said, adding that Richter believed the product should not be suspended.